Insights Blog

Clinical Site Regulatory Processes: The Case for Standards

Posted on Jun 18, 2018 9:00:00 AM
“Uncontrolled variation is the enemy of quality.” 

-- William Edwards Deming 

The concept of standards is not new.

People throughout time, in all eras, geographies, and industries have looked to create standards as a way to improve efficiency and reduce variance of outcomes.

For instance, King Henry I of England standardized measurement in 1120 AD by instituting the ell, which was equivalent to the length of his arm. Another example is that the Egyptians were the first to develop the 365-day calendar and are often credited with logging 4236 BC as the first year in recorded history. In 2009, a cross-section of life science companies, contract research organizations, technical vendors, industry groups and others established the Trial Master File (TMF) Reference Model to develop a standardized taxonomy and nomenclature for organization of TMF content.

The long-term goal driving individuals and groups to establish a set of standards is that a system can be built upon the foundation of those standards.

If development of standards is a proven methodology to lead to efficiency and quality, why is it not more widely applied at clinical research sites and institutions?

Take for example a common challenge faced by research staff. If a Regulatory Coordinator at a research institution switches departments or specialties, they are often forced to learn a completely new process for how to manage their regulatory documents and organize their binders, according to “how it’s always been done” at the new department.

Here is a non-comprehensive list of regulatory processes that often vary greatly between departments inside of an institution and more generally from institution to institution:

  1. Training and safety report dispersal and acknowledgement
  2. IRB submissions
  3. Document naming and filing conventions
  4. Delegation of authority log management
  5. Protocol and Informed Consent Form version control
  6. Staff credentials

Additionally, many sites and institutions conducting clinical research have decided that it’s simply easiest to receive instruction and guidance from their industry sponsor(s) on how the trial will be conducted, how the binders will be organized, etc.

What you end up with is a scenario where that institution is working with 20 different industry sponsors, has 20 different standards to follow, which then translates to 20 different systems.

How are you supposed to scale and grow your research operating in this fashion?

Thinking about quality, operating in a system built upon standards creates confidence that the same outcome will occur, every time. In those rare cases where a different outcome occurs, you now have a framework in place to review compliance with the standard and quickly identify any deviations and what caused them. Quality assurance becomes simpler, continually ongoing, and an integrated component of the institution, underlying every day-to-day task and decision made by staff.

The decision to implement an eRegulatory solution offers research institutions an opportunity to standardize clinical trial documentation and processes.

A key point of distinction here is that an eRegulatory system, by itself, does not build and put in place the standards for an institution. It is a catalyst for that development and collaboration process to begin. The institution either needs to define the standard for itself from the ground up, or partner with a knowledgeable vendor who can leverage their expertise, experience, and collective best practices to build upon. Furthermore, the right solution can automate regulatory processes, to improve efficiency and ensure adherence to SOPs.

Ultimately, compliance with FDA and ICH GCP regulations and guidelines is the responsibility of the site conducting the trial - not the sponsor, CRO, or others. With that said, wouldn’t it be simpler to follow your institution’s own set of standards and SOPs to ensure compliance and confidence, rather than juggling the many different standards and systems forced upon you?

Topics: eRegulatory, Standardization, Automation


Paul Baechtold

Written by Paul Baechtold

Paul Baechtold works with clinical research sites and institutions to maximize workflow efficiency and compliance. As a continual learner and business development professional, he is passionate about education and making meaningful connections with colleagues across many industries and from different backgrounds to challenge the status quo.

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